prebiotic food-enriched diet (prefed) to enhance the microbiome and response to first-line immunotherapy in unresectable melanoma

Conditions: Unresectable Melanoma

Summary: to learn about the possible effects of a prebiotic food-enriched diet (prefed) targeting the gut microbiome in participants with melanoma who are starting immune checkpoint blockade (icb) therapy.

primary objectives • evaluate the effect of dietary intervention on the abundance of faecalibacterium in stool samples from baseline to 12 weeks secondary objectives * determine the best overall response rate (borr) to prefed + icb regimens and landmark orr at 12 weeks (intervention) and 24 weeks (maintenance) * determine progression-free survival (pfs) and overall survival (os) with prefed + icb regimens * compliance and adherence to the dietary intervention at 12 weeks and maintenance at 24 weeks * determine the safety (diet-related aes) and tolerability (gsrs-ibs) of the dietary intervention at 12 weeks and maintenance at 24 weeks * assess the rate of immune related adverse events in patients on icb regimens receiving dietary intervention at 12 weeks and maintenance at 24 weeks * assess the effects of dietary intervention on systemic and tumor immunity * assess the effect of dietary intervention on overall gut microbiome composition and networks at 12 weeks and maintenance at 24 weeks * assess the effects of dietary intervention on gut metabolic output and systemic metabolism at 12 weeks and maintenance at 24 weeks * assess the effects of dietary interventions on quality of life and other patient reported outcomes (pros) at 12 weeks and maintenance at 24 weeks

Eligibility criteria:
inclusion criteria: * age ≥18 years old * able to self-complete study assessments monitoring diet and gastrointestinal symptom burden * body mass index (bmi) 18.5-45 kg/m2 * ecog performance status of 0 or 1 * histologically confirmed stage iii/iv, unresectable cutaneous, uveal, acral, or mucosal melanoma. asymptomatic brain metastases are allowed. * planned initiation of 1st line standard-of-care approved immune checkpoint blockade (anti-pd1 +/- anti-ctla4 or anti-lag3 inhibitors) in the metastatic setting (prior icb in adjuvant setting is allowed if last exposure ≥ 6 months prior). prior targeted therapy is also allowed. * returning to md anderson for restaging and follow-up (icb treatment may occur locally) * wocp must have negative upt within 1 week of beginning dietary intervention. * self-reported willingness to eat the provided foods (with some tailoring to their food preferences) * self-reported willingness to comply with scheduled visits, undergo venipuncture, provide stool samples. exclusion criteria: * previous icb treatment in the metastatic setting * history of inflammatory bowel disease, total colectomy, or bariatric surgery. * currently taking steroids \> prednisone 10 mg/day or equivalent * medical contraindications to the intervention diet as determined by the treating physician. * self-reported major dietary restrictions, including but not limited to relevant food allergies, celiac disease, or diets such as vegan, ketogenic, extended fasting. * insulin-dependent diabetes or condition requiring bile acid sequestrants * unable or unwilling to undergo study procedures. * iv antibiotic use in the past month or oral antibiotic use in past 2 weeks. * regularly taking supplements containing prebiotics, fiber and/or probiotics, and unable/unwilling to discontinue for the purpose of the study. * current smoker or heavy drinker (defined as \>14 drinks per week) or current illicit drug use. * currently pregnant, planning to become pregnant, or lactating. * concurrent malignancy requiring systemic therapy other than hormonal therapy. * cognitively impaired adults